Zymeworks Inc. (“Zymeworks”), a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, initially focused on the treatment of cancer, today announced that its lead product candidate, ZW25, has been granted orphan drug designation from the U.S. Food and Drug Administration (the “FDA”) in the treatment of gastric cancer, including cancer of the gastroesophageal junction (“GEJ”).
“Gastric Cancer represents ZW25’s second orphan drug designation, in addition to ovarian cancer, which was granted last year,” said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. “Gastric cancer is the fifth most common cancer in the world, and we believe ZW25 has the potential to address the significant unmet medical need that exists for patients with this disease.”
Dr. Diana Hausman, Zymeworks’ Chief Medical Officer, added, “ZW25 demonstrated encouraging anti-tumor activity in preclinical models of gastric cancer. We are excited about the opportunity to advance the development of ZW25, which is currently being evaluated in a first in human Phase 1 clinical trial in the US in patients with advanced HER2 expressing cancers, including gastric/GEJ tumors.”
The FDA grants orphan drug designation to biological products that are intended to treat a rare disease or condition, which is generally defined as affecting a patient population of fewer than 200,000 people in the United States. Orphan drug designation provides the sponsor certain financial incentives, including tax credits, the waiver of associated application fees, and a period of marketing exclusivity if the product candidate receives the first marketing approval for the indication for which it has such designation.